CARIDEX(TM) REMOVAL SYSTEM
FDA premarket approval P830035/S002 · decided 1985-08-28
Approval details
- PMA number
- P830035
- Supplement
- S002
- Trade name
- CARIDEX(TM) REMOVAL SYSTEM
- Generic name
- SOLUTION, REMOVAL, CARRIES
- Applicant
- Indevus Pharmaceuticals, Inc.
- Date received
- 1985-05-13
- Decision date
- 1985-08-28
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- LMW
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Cranbury, NJ
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.